- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05392309
Manual Ankle Rocking Training on Postural Control and Foot Function in Children With Down Syndrome
January 4, 2023 updated by: Riphah International University
Effects of Manual Ankle Rocking Training on Postural Control and Foot Function in Children With Down Syndrome
Down syndrome occurs due to abnormal cell division of extra chromosome 21.
It is a genetic disorder that causes postural un stability, leads to poor foot function and causes them difficulty that they can't fulfill their daily life activities and can't be independent.
Strengthening exercise of lower limb and core strengthening of trunk muscle will provide postural stability and lower limb strengthening.
Aim of this research is to determine the effects of manual Ankle rocking training on postural control and foot function in children with Down syndrome.
Those who are diagnosed with down syndrome and are between age 8-15 and both of the genders are included in this research and those who have any surgical issue, visual impairment and musculoskeletal contractures are not included in the study we will use static standing balance test to check postural control and foot function index for Ankle rocking training from two group in which one will be given the baseline treatment of lower limb exercise and core strengthening with ankle rocking training and the other group without ankle rocking training and then the collected data will be analyzed by SPSS.
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Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Rising Sun Institute For Special Children, Lahore
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed children with down syndrome
- Age 8 to 15
- Both gender (male and female)
Exclusion Criteria:
- Musculoskeletal contractures
- Visual or other sensory input impairment
- Any surgical procedure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Manual ankle rocking training
Group will receive manual ankle rocking training with lower limb exercise and core strengthening of trunk
|
Group will receive manual ankle rocking training with lower limb exercise and core strengthening of trunk
Group will receive lower limb exercises and core strengthening of trunk.
Sessions will be 4 days in a week
|
Active Comparator: conventional
Group will receive lower limb exercises and core strengthening of trunk.
Sessions will be 4 days in a week
|
Group will receive lower limb exercises and core strengthening of trunk.
Sessions will be 4 days in a week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in foot function index score
Time Frame: Baseline and 9th week
|
A Foot Function Index (FFI) was developed in 1991 to measure the impact of foot pathology on function in terms of pain, disability and activity restriction.
It is a self-administered index consisting of 23 items divided into 3 sub-scales.
Both total and sub-scale scores are produced.
|
Baseline and 9th week
|
Static standing balance test
Time Frame: baseline and 9th week
|
Static standing balance test for postural control and stability
|
baseline and 9th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sidra Afzal, PP-DPT, Riphah international university
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Balan V, Georgescu M. Postural control in Down syndrome subjects. European Proceedings of Social and Behavioural Sciences. 2019;11.
- Palomba A, Perez D, Tafuri D. THE EFFECTS OF PHYSICAL ACTIVITY ON BALANCE AND POSTURAL CONTROL IN PEOPLE WITH DOWN SYNDROME.
- Shields N, Lim P, Wollersheim D, Nikolopoulos N, Barrett J, Evans A, et al. Do foot posture, deformity, and footwear fit influence physical activity levels in children with Down syndrome? A prospective cohort study. Journal of Intellectual & Developmental Disability. 2017;42(4):332-8
- Wang HY, Long IM, Liu MF. Relationships between task-oriented postural control and motor ability in children and adolescents with Down syndrome. Res Dev Disabil. 2012 Nov-Dec;33(6):1792-8. doi: 10.1016/j.ridd.2012.05.002. Epub 2012 Jun 13.
- Eltohamy AM, Mahran MA, Elassal MI, Kamel AH. Ankle Rocking Training and Functional Abilities in Children with Cerebral Palsy. The Egyptian Journal of Hospital Medicine. 2021;85(1):3301-5
- Chen HL, Yeh CF, Howe TH. Postural control during standing reach in children with Down syndrome. Res Dev Disabil. 2015 Mar;38:345-51. doi: 10.1016/j.ridd.2014.12.024. Epub 2015 Jan 13.
- Brugnaro BH, Oliveira MFP, de Campos AC, Pavao SL, Rocha NACF. Postural control in Down syndrome and relationships with the dimensions of the International Classification of Functioning, Disability and Health - a systematic review. Disabil Rehabil. 2022 Jun;44(11):2207-2222. doi: 10.1080/09638288.2020.1830439. Epub 2020 Oct 13.
- Zago M, Duarte NAC, Grecco LAC, Condoluci C, Oliveira CS, Galli M. Gait and postural control patterns and rehabilitation in Down syndrome: a systematic review. J Phys Ther Sci. 2020 Apr;32(4):303-314. doi: 10.1589/jpts.32.303. Epub 2020 Apr 2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2022
Primary Completion (Actual)
September 15, 2022
Study Completion (Actual)
October 31, 2022
Study Registration Dates
First Submitted
May 23, 2022
First Submitted That Met QC Criteria
May 23, 2022
First Posted (Actual)
May 26, 2022
Study Record Updates
Last Update Posted (Actual)
January 5, 2023
Last Update Submitted That Met QC Criteria
January 4, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0704
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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